AppendicitisIFFSANCT01953289
Importance of Peritoneal Free Fluid Cultures in Acute Appendicitis
An observational study of Appendicitis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The purpose of this study is to evaluate the frequency of positive free fluid cultures in both perforated and non-perforated appendicitis. In addition predictors of positive free fluid cultures will be analyzed. Read more about this study
- Who is it for?
- Ages 6 to 90 years
- Conditions the study is for
- Appendicitis
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2012to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with perforated or non-perforated appendicitis
Who may be able to join
- Appendicitis (Perforated/ Non-perforated) Free fluid Age: 6 - 90y
Who cannot join
- Immunosuppression (recent chemotherapy, chronic use of immunosuppressive medication) Age < 6 and > 90y
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Importance of Peritoneal Free Fluid Cultures in Both Perforated and Non-perforated Appendicitis
The purpose of this study is to evaluate the frequency of positive free fluid cultures in both perforated and non-perforated appendicitis. In addition predictors of positive free fluid cultures will be analyzed.
Read the detailed description
Prior to surgery, all patients will receive antibioprophylaxis. In case of free peritoneal fluid, a sample is aspirated and sent for microbiology. A lavage with saline is not necessary. The decision to start postoperative antibiotic is left at the discretion of the surgeon. The decision to leave an abdominal drain is left at the discretion of the surgeon.
The use of a preoperative single dose administration of antibiotics has been extensively studied and found beneficial in the prevention of SSI in appendicitis. However, the use of continued postoperative antibiotics has barely been studied. The sparse evidence that exist does not seem to support its systematic use. During appendectomy the surgeon frequently encounters turbid free fluid, even in non-perforated appendicitis. It is common practice in Belgium to continue antibiotic prophylaxis for 5 days after aspiration and lavage. Although the aspect often seems purulent, it is unknown in what percentage this fluid is contaminated. Also, it is unknown whether after aspiration and lavage intra-abdominal drains are necessary.
- Conditions
- Appendicitis
- Keywords
- Appendicitis, Free fluid
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Appendicitis | Free fluid in perforated or non-perforated appendicitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the frequency of positive free fluid cultures in both perforated and non-perforated appendicitis
In case of free peritoneal fluid, a sample will be aspirated and sent for microbiology.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2013 (estimated)
- Study startJul 2012
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Sub investigator is working no longer in the hospital. No participants were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- André JL D'Hoore, PhD, Principal investigator, university Clinics Gasthuisberg department of abdominal surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01953289
- Sponsor's protocol ID
- S-54473
- Acronym
- IFFSA
- Status last verified
- Jul 2015
- First submitted
- 19 Feb 2013
- Last updated
- 7 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Importance of Peritoneal Free Fluid Cultures in Both Perforated and Non-perforated Appendicitis
- ClinicalTrials.gov ID
- NCT01953289
- Acronym / sponsor ID
- IFFSA / S-54473
- Conditions
- Appendicitis
- Keywords
- Appendicitis, Free fluid
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Sub investigator is working no longer in the hospital. No participants were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 30 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the frequency of positive free fluid cultures in both perforated and non-perforated appendicitis. In addition predictors of positive free fluid cultures will be analyzed.
Detailed description
Prior to surgery, all patients will receive antibioprophylaxis. In case of free peritoneal fluid, a sample is aspirated and sent for microbiology. A lavage with saline is not necessary. The decision to start postoperative antibiotic is left at the discretion of the surgeon. The decision to leave an abdominal drain is left at the discretion of the surgeon.
The use of a preoperative single dose administration of antibiotics has been extensively studied and found beneficial in the prevention of SSI in appendicitis. However, the use of continued postoperative antibiotics has barely been studied. The sparse evidence that exist does not seem to support its systematic use. During appendectomy the surgeon frequently encounters turbid free fluid, even in non-perforated appendicitis. It is common practice in Belgium to continue antibiotic prophylaxis for 5 days after aspiration and lavage. Although the aspect often seems purulent, it is unknown in what percentage this fluid is contaminated. Also, it is unknown whether after aspiration and lavage intra-abdominal drains are necessary.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Appendicitis | – | –Free fluid in perforated or non-perforated appendicitis |
Who may qualify
- Ages
- 6 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with perforated or non-perforated appendicitis
Key inclusion criteria (1 listed)
- Appendicitis (Perforated/ Non-perforated) Free fluid Age: 6 - 90y
Key exclusion criteria (1 listed)
- Immunosuppression (recent chemotherapy, chronic use of immunosuppressive medication) Age < 6 and > 90y
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the frequency of positive free fluid cultures in both perforated and non-perforated appendicitis
Time frame: 24 hours
In case of free peritoneal fluid, a sample will be aspirated and sent for microbiology.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2015.
Related trials for Appendicitis
RecruitingObservational study
Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
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PAINED: Project Addressing INequities in the Emergency Department
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Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
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Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
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RecruitingPhase 3
Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
Complicated Appendicitis, Intra-Abdominal Abscess
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
André JL D'Hoore, PhD principal investigator
university Clinics Gasthuisberg department of abdominal surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Appendicitis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the frequency of positive free fluid cultures in both perforated and non-perforated appendicitis (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2015.